Firmware Engineer

microTECH Global LTD; Cambridge; On-site; GBP 90,000 - 130,000; Full time

Job summary

microTECH Global LTD is seeking a Senior/Staff Medical Firmware Engineer to design, develop, and maintain safety-critical embedded firmware for regulated medical devices, focusing on insulin pump systems. The role requires leadership in architecture, requirements, and design from early concept through release, with ISO 13485, IEC 62304, and ISO 14971 expertise.

Collaborate with Quality and Regulatory teams to define QMS processes and generate audit-ready documentation.

Qualifications

• 5+ years hands-on experience developing firmware for regulated medical devices.
• Experience in ISO 13485 environments and regulated medical device software lifecycle.

Responsibilities

• Design, develop, and maintain safety-critical embedded firmware for insulin pump systems.
• Lead firmware architecture from concept to product release.
• Ensure compliance with ISO 13485, IEC 62304, and ISO 14971.
• Act as firmware compliance lead on requirements, traceability, risk control, verification, and evidence.

Skills

Embedded firmware

Regulatory compliance

Quality systems

IEC 62304

ISO 13485

Requirements management

Architecture leadership

Traceability

FDA submissions

Tools

C programming

Job description

We are seeking a Senior / Staff Medical Firmware Engineer with deep, hands-on experience developing regulated medical device firmware to join our growing medical devices team.

Key Responsibilities

• Design, develop, and maintain safety-critical embedded firmware for regulated medical devices, with a focus on insulin pump systems.
• Lead firmware architecture, requirements definition, and design from early concept through product release.
• Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971.
• Act as the firmware compliance leader, guiding the team on requirements management, traceability, risk control implementation, verification strategy, and evidence generation.
• Work closely with Quality and Regulatory teams to define, implement, and maintain firmware-related QMS processes, templates, and work instructions.
• Produce, review, and approve key firmware deliverables including requirements, architecture and design documentation, risk analyses, traceability matrices, and verification reports.

Skills & Experience

• 5+ years hands-on experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages.
• Demonstrated experience working within an ISO 13485–certified Quality Management System.
• Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software.
• Strong embedded programming skills in C and experience developing robust, maintainable safety-critical code.
• Experience producing audit-ready and submission-ready software documentation and compliance evidence.
• Experience collaborating closely with Quality, Regulatory, Systems, and Hardware engineering teams.
• Experience supporting FDA submissions (e.g. 510(k)) and/or EU MDR technical documentation is highly desirable.
• Experience establishing, improving, or scaling firmware development processes in a regulated environment is a strong advantage.

What Success Looks Like in the First 6–12 Months

• Firmware development for the insulin pump platform is established and operating consistently within the ISO 13485 Quality Management System.
• Clear and well-understood firmware lifecycle processes are in place and followed across the team.
• Requirements, risks, implementation, and verification are fully traceable and audit-ready.
• The firmware organisation demonstrates confidence and maturity during regulatory interactions and audits.
• Firmware engineers are coached and empowered to deliver compliant medical device software independently.